Braeburn Announces FDA Acceptance with Priority Review of New Drug Application for CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder

PRINCETON, NJ, USA I September 18, 2017 I Braeburn Pharmaceuticals, Inc. (Braeburn) announces that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) with Priority Review designation for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). The NDA for CAM2038, which was submitted on July 19, 2017, comprises data from five Phase 1-2 clinical trials as well as two Phase 3 trials.

"FDA's acceptance of our NDA for CAM2038 under Priority Review represents an important step in advancing Braeburn's mission to provide opioid use disorder patients with effective treatment options which can be individualized to support them throughout their recovery – from initiation and stabilization, to longer-term maintenance," said Mike Derkacz, President and CEO of Braeburn.  "Because the weekly and monthly formulations are administered by healthcare professionals and remain in their control, if approved, CAM2038 may help mitigate the inherent risks of daily oral medication in terms of diversion, misuse and pediatric exposure."

A core component of the NDA submission is the positive results from a pivotal Phase 3 randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine (CAM2038) in patients with OUD. This study enrolled a wide OUD population including patients who had concomitant use of other non-opioid substances of abuse, such as amphetamines, cocaine, marijuana, and benzodiazepines. The study also initiated treatment immediately without a need for any prior induction period.  In addition to achieving the primary endpoint (response rate) of non-inferiority versus treatment with daily sublingual buprenorphine/naloxone, the current standard of care, CAM2038 also demonstrated superior treatment effect for the secondary endpoint (Cumulative Distribution Function of the percentage of urine toxicology negative for illicit opioids confirmed by self-report). The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events.

FDA has granted Fast Track and Priority Review designations for CAM2038 buprenorphine weekly and monthly depot for the treatment of opioid use disorder and will convene an Advisory Committee meeting for CAM2038 in Q4 2017. Additionally, FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 19, 2018.

About CAM2038

CAM2038 buprenorphine weekly and monthly depot subcutaneous injection is an investigational treatment of opioid use disorder, as a part of a comprehensive treatment plan to include counseling and psychosocial support. The product is designed for flexible and individualized treatment from initiation and stabilization to longer-term maintenance therapy, providing sustained buprenorphine release in once weekly and once monthly formulations. Administration by healthcare professionals ensures delivery and medication adherence, while potentially minimizing risks of diversion, misuse, and accidental pediatric exposure. CAM2038 has been successfully evaluated in seven Phase 1-3 clinical trials, including a pivotal Phase 3 efficacy and a long-term safety study. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events.

CAM2038 is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional. If approved, CAM2038 will be offered in dosage strengths for once weekly (8 mg to 32 mg range) and once monthly (64 mg to 160 mg) subcutaneous injections.

About Braeburn Pharmaceuticals

Braeburn is a pharmaceutical company dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid addiction. The company's mission is to advance a portfolio of next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of addiction faced by patients, healthcare professionals, payers and society.

SOURCE: Braeburn Pharmaceuticals

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